Chewable pharmaceutical dosage units, such as soft chews, are known and have been commercialized for companion animals. Formulation of a drug into a chewable dosage form can increase (animal) patient acceptance of the medication that tend to resist swallowing hard tablets or capsules and even make the animals take up the dosage form free choice.
Texture is important for the acceptance of such oral dosage units by (animal) patients. One of the most commonly used form for chewable pharmaceutical dosage units is a chewable compressed tablet, whose ingredients, however, can make the tablet gritty or otherwise unappealing, especially to non-human animals. Thus, a preferred alternative dosage form for non-human animals is the “soft chew”, generally a meat-like mass also widely found in consumable pet treats.
Soft chewable pharmaceutical dosage units (Soft chews) have been described in the prior art. U.S. Pat. No. 6,387,381 discloses an extrudate which is formed of a matrix having starch, sugar, fat, polyhydric alcohol and water.
WO 2004/014143 relates to compositions and processes for the delivery of an additive to an organism in a form suitable for consumption, and in particular, in the form of a soft chew.
US 2009/0280159 and US 2011/0223234, relate to palatable edible soft chewable medication vehicles. The processes described herein relate to the problem that heat generated during the extrusion process causes deterioration in the stability of the active ingredient in the mixture.
Machines for the production of moulded food patties have been described to be useful for the manufacturing of soft chews for administration to non-human animals. Such machines are moulding machines that have been originally developed for use in producing moulded food products, for example the Formax F6™ moulding machine made by the Formax Corporation or the moulding machines disclosed in U.S. Pat. Nos. 3,486,186; 3,887,964; 3,952,478; 4,054,967; 4,097,961; 4,182,003; 4,334,339; 4,338,702; 4,343,068; 4,356,595; 4,372,008; 4,535,505; 4,597,135; 4,608,731; 4,622,717; 4,697,308; 4,768,941; 4,780,931; 4,818,446; 4,821,376; 4,872,241; 4,975,039; 4,996,743; 5,021,025; 5,022,888; 5,655,436; and 5,980,228.
Such machines are originally used to form e.g. hamburger patties from a supply of ground beef by forcing the ground beef under pressure into a multi-cavity mould plate which is rapidly shuttled on a linear slide between a fill position and a discharge position in which vertically reciprocable knock-outs push the patties from the mould cavities. A schematic drawing of such a machine is shown in FIG. 1.
However, it has been observed that with such forming machines there are limitations regarding the size and weight of soft chewable pharmaceutical dosage units that can be produced in the desired quality on large scale.
Accordingly, an alternative process for producing such soft chewable pharmaceutical dosage units and other semi-plastic pharmaceutical dosage units on an industrial scale would be desirable.
Rotary moulding machines are known for the manufacturing of confectionery such as marzipan, fondant, nut compositions, fruit compositions, fudge, caramel, nougat, coconut compositions and the like.
It has now been found that semi-plastic pharmaceutical dosage units, e.g. soft chews, that are formed with a rotary moulding machine have desirable properties and address the problems of the prior art.